Wanner, Christoph
Schuchhardt, Johannes
Bauer, Chris
Lindemann, Stefanie
Brinker, Meike
Kong, Sheldon X.
Kleinjung, Frank
Horvat-Broecker, Andrea
Vaitsiakhovich, Tatsiana
Funding for this research was provided by:
Bayer
Article History
Received: 17 January 2022
Accepted: 20 April 2022
First Online: 14 May 2022
Declarations
:
: CW reports advisory board and lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Eli-Lilly, MSD, and Mundipharma. CB and JS are employees of MicroDiscovery GmbH, Berlin, Germany. SL, FK, and TV are employees of Bayer AG, Berlin, Germany. MB and AHB are employees of Bayer AG, Wuppertal, Germany. SK is an employee of Bayer Pharmaceuticals, Whippany, New Jersey, USA.
: This analysis was a retrospective, observational, real-world study using a secondary data source.
: Our institutional review board determined that the FLIEDER study is exempt from institutional review board oversight because it does not constitute research involving human subjects according to 45 CFR 46.102(f). The data included in the Optum CDM database are de-identified and are in compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 to preserve participant anonymity and confidentiality, and as such this study followed the principles of the declaration of Helsinki without the requirement for review from a formal ethics review committee.